The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

September 15, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Infertility, Female
Interventions
DRUG

Erzhi Tiangui Granule

The Drug Manufacturing Unit of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine produced the EZTG granule.The EZTG was packaged as 3 g/bag, batch number 01-FZ032-03. The daily dose is equivalent to 15g of Ligustrum lucidum (Nv Zhen Zi),15g of Lotus japonicus (Han Lian Cao),15g of the fruit of Chinese wolfberry(Gou Qi Zi),15g of Cuscuta chinensis(Tu Si Zi), 15g of Radix Rehmanniae Preparata(Shu Di Huang),12g of Angelica sinensis(Dang Gui),12g of Paeonia lactiflora(Bai Shao),12g of Ligusticum wallichii(Chuan Xiong),12g of Rhizoma cyperi(Xiang Fu),and 9g of Radix Glycyrrhizae (Zhi Gan Cao).The placebo granule,which was Preparata mainly composed of dextrin, was made in a similar color and shape to EZTG.Placebo granules were packaged as 3g/bag, with the same package of the EZTG, batch number 01-FZ032-03-1. The EZTG or placebo was orally administered after being dissolved in water, 3g each time, 2 times a day.

DRUG

Erzhi Tiangui Placebo

The placebo consisted mainly of yellow bean powder, starch, carbogen, molasses and could mimic the appearance, color and smell of Erzhi Tiangui granules, but without any active ingredients. Daily doses of placebo were delivered in the same packaging as Erzhi Tiangui granules.

Trial Locations (1)

250014

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan

All Listed Sponsors
collaborator

The 960th Hospital of the PLA Joint Logistics Support Force

UNKNOWN

collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

collaborator

Maternity and Child Health Care of Zaozhuang

UNKNOWN

collaborator

Yantai Shan Hospital

UNKNOWN

collaborator

Maternal and Child Health Care Hospital of Shandong Province

UNKNOWN

collaborator

Hospital for Reproductive Medicine Affiliated to Shandong University

UNKNOWN

collaborator

Chongqing Medical Center for Women and Children

OTHER

collaborator

The Second Hospital of Hebei Medical University

OTHER

lead

Shandong University of Traditional Chinese Medicine

OTHER